Label: FERROUS SULFATE ENTERIC-COATED- ferrous sulfate tablet

  • NHRIC Code(s): 0245-0108-11, 0245-0108-10, 0245-0108-01, 0245-0108-89
  • Packager: Upsher-Smith Laboratories. LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 15, 2024

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 Tablet
    Amount per Serving% Daily Value
    Iron
    (as dried ferrous sulfate)    		65 mg361%

    Other Ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, anhydrous lactose, hypromellose phthalate, croscarmellose sodium, stearic acid, magnesium stearate, triacetin, FD&C Red #40 aluminum lake, colloidal silicon dioxide, titanium dioxide, hypromellose, mineral oil.

    Contains: Milk

  • Directions

    Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: Consult a physician. Do not chew or crush tablet.

    Tablets are enteric-coated to help protect your stomach.

  • SAFE HANDLING WARNING

    Store in a cool, dry place. Protect contents from light and moisture.

  • Caution

    Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron-containing products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • WARNINGS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.
  • HEALTH CLAIM

    DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN, OR MISSING.

  • Questions or comments?

    1-800-650-3789 Mon–Fri 8am to 5pm CST

  • HEALTH CLAIM

    Distributed by
    UPSHER-SMITH LABORATORIES, LLC
    Maple Grove, MN 55369

    © 2024 Upsher-Smith Laboratories, LLC

    CC8-02450108-11
    133R R0324

  • PRINCIPAL DISPLAY PANEL - 325 mg Blister Pack Label

    List 0245-0108-11

    Ferrous Sulfate
    Enteric-Coated
    Tablets

    Dietary Supplement

    325 mg

    100 Tablets

    UPSHER-SMITH

    PRINCIPAL DISPLAY PANEL - 325 mg Blister Pack Label
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE  ENTERIC-COATED
    ferrous sulfate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0245-0108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ferrous Sulfate (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0245-0108-11100 in 1 BOTTLE
    2NHRIC:0245-0108-101000 in 1 BOTTLE
    3NHRIC:0245-0108-014 in 1 CARTON
    3NHRIC:0245-0108-8925 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement07/22/2002
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)10 mm
    Labeler - Upsher-Smith Laboratories. LLC (079111820)
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